Ophthalmic Antihistamines Are Commonly Used in the Treatment of Both Allergic Conjunctivitis and Allergic Rhinitis

Policy: Ophthalmic Antihistamine Annual Review Date: 02/18/2021 Preferred Step Therapy

Last Revised Date: 02/18/2021

Drugs Affected: • Alrex® (loteprednol etabonate 0.2% ophthalmic suspension – Bausch & Lomb/Valeant) • azelastine hydrochloride 0.05% ophthalmic solution (generics only) • Bepreve® (bepotastine besilate 1.5% ophthalmic solution – Bausch & Lomb/Valeant) • Elestat® (epinastine hydrochloride 0.05% ophthalmic solution – Allergan, generics) • Emadine® (emedastine difumarate 0.05% ophthalmic solution – Alcon/Novartis) • Lastacaft® (alcaftadine 0.25% ophthalmic solution – Allergan) • Pataday® (olopatadine hydrochloride 0.2% ophthalmic solution – Alcon/Novartis, generics) • Patanol® (olopatadine hydrochloride 0.1% ophthalmic solution – Alcon/Novartis, generics) • Pazeo® (olopatadine hydrochloride 0.7% ophthalmic solution – Alcon/Novartis) • Zerviate® (cetirizine hydrochloride 0.24% ophthalmic solution – Akon)

OVERVIEW Conjunctivitis is inflammation of the outer lining of the eye, known as the conjunctiva. Conjunctivitis may be infectious or non-infectious; common types of non-infectious conjunctivitis include allergic, mechanical/irritative/toxic, and neoplastic. Allergic conjunctivitis affects an estimated 40% of the population and can be further categorized into seasonal, vernal, atopic, and giant papillary conjunctivitis. The most common predisposing factors to allergic conjunctivitis include exposure to environmental allergens, hot/dry climates, genetic predisposition to atopy, and contact lens wear. Allergic rhinitis is often accompanied by symptoms of allergic conjunctivitis. Ophthalmic antihistamines are commonly used in the treatment of both allergic conjunctivitis and allergic rhinitis.

POLICY STATEMENT A step therapy program has been developed to encourage use of one Step 1 product prior to the use of a Step 2 product. If the step therapy rule is not met for a Step 2 agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration.

Automation: Patients with a history of one Step 1 drug within the 130-day look-back period are excluded from step therapy.

Step 1: generic azelastine ophthalmic solution, generic epinastine ophthalmic solution, prescription generic olopatadine 0.1% ophthalmic solution, prescription generic 0.2% olopatadine ophthalmic solution

Step 2: Zerviate, Alrex, Bepreve, Elestat (discontinued), Emadine (discontinued), Lastacaft, prescription Pataday (discontinued), prescription Patanol (discontinued), prescription Pazeo (discontinued)

This document is subject to the disclaimer found at https://www.medmutual.com/For-Providers/Policies-and-Standards/CorporateMedicalDisclaimer.aspx and is subject to change. https://www.medmutual.com/For-Providers/Policies-and-Standards/Prescription-Drug-Resources.aspx

CRITERIA

1. If the patient has tried one Step 1 product, authorization for a Step 2 product may be given.

2. Authorization may be given for Alrex if the patient requires the concurrent use of Alrex and an H1 antagonist (e.g., Emadine) or an H1 antagonist/mast cell stabilizer (e.g., azelastine ophthalmic solution, epinastine ophthalmic solution, Bepreve, Lastacaft, olopatadine 0.1% ophthalmic solution, olopatadine 0.2% ophthalmic solution, Pazeo).

3. Authorization may be given for Alrex if the patient has tried a different ophthalmic steroid for the current condition.

Initial Approval/ Extended Approval. A) Initial Approval: 365 days (1 year) B) Extended Approval: 365 day (1 year)

Step Therapy Exception Criteria In certain situations, the patient is not required to trial preferred agents. Approve for 1 year if the patient meets the following (A, B, or C): A. The patient has an atypical diagnosis and/or unique patient characteristics which prevent use of all preferred agents. If so, please list diagnosis and/or patient characteristics [documentation required]; OR B. The patient has a contraindication to all preferred agents. If so, please list the contraindications to each preferred agent [documentation required]; OR C. The patient is continuing therapy with the requested non-preferred agent after being stable for at least 90 days [verification in prescription claims history required] or, if not available, [verification by prescribing physician required] AND meets ONE of the following: 1. The patient has at least 130 days of prescription claims history on file and claims history supports that the patient has received the requested non-preferred agent for 90 days within a 130-day look-back period AND there is no generic equivalent available for the requested nonpreferred product (i.e. AA-rated or AB-rated to the requested nonpreferred product); OR 2. When 130 days of the patient’s prescription claims history file is unavailable for verification, the prescriber must verify that the patient has been receiving the requested non-preferred agent for 90 days AND that the patient has been receiving the requested non-preferred agent via paid claims (i.e. the patient has NOT been receiving samples or coupons or other types of waivers in order to obtain access to the requested non-preferred agent) AND there is no generic equivalent available for the requested nonpreferred product (i.e. AA-rated or AB-rated to the requested nonpreferred product).

Documentation Required: When documentation is required, the prescriber must provide written documentation supporting the trials of these other agents, noted in the criteria as [documentation required]. Documentation should include chart notes, prescription claims records, and/or prescription receipts.

Approval Duration: All approvals for continuation of therapy are provided for 1 year unless noted otherwise below. In cases where the initial approval is authorized in months, 1 month is equal to 30 days.

Documentation Requirements:

The Company reserves the right to request additional documentation as part of its coverage determination process. The Company may deny reimbursement when it has determined that the drug provided or services performed were not medically necessary, investigational or experimental, not within the scope of benefits afforded to the member and/or a pattern of billing or other practice has been found to be either inappropriate or excessive. Additional documentation supporting medical necessity for the services provided must be made available upon request to the Company. Documentation requested may include patient records, test results and/or credentials of the provider ordering or performing a service. The Company also reserves the right to modify, revise, change, apply and interpret this policy at its sole discretion, and the exercise of this discretion shall be final and binding.

REFERENCES 1. Varu DM, Rhee MK, Akpek EK, et al. American Academy of Ophthalmology Preferred Practice Pattern Cornea and External Disease Panel. Opthalmology. 2018 Oct 23. [Epub ahead of print]. 2. Patanol® solution [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; April 2018. 3. Azelastine solution [prescribing information]. Lake Forest, IL: Akorn, Inc.; November 2017. 4. Elestat® solution [prescribing information]. Irvine, CA: Allergan, Inc.; January 2012. 5. Pataday™ [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; February 2017. 6. Bepreve® solution [prescribing information]. Bridgewater, NJ: Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC; February 2018. 7. Lastacaft® solution [prescribing information]. Irvine, CA: Allergan, Inc.; February 2016. 8. Emadine® solution [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc.; October 2018. 9. Alrex® suspension [prescribing information]. Bridgewater, NJ: Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC; May 2016. 10. Zaditor® Drug Facts. Fort Worth, TX: Alcon Laboratories, Inc.; October 2018. 11. Alaway® Drug Facts. Tampa, FL: Bausch & Lomb Pharmaceuticals, Inc.; August 2015. 12. Pazeo® solution [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; April 2017. 13. Zerviate solution [prescribing information]. Lake Forest, IL: Akorn Inc; May 2017.